PACTR202311505748497尚未招募2 期
A phase 2, partially-blinded, randomised trial assessing the safety and efficacy of TBAJ876 or bedaquiline, in combination with pretomanid and linezolid in adult participants with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- TB Alliance
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1. Signed written informed consent prior to undertaking any trial-related procedures.
- •2. Participants aged 18 to 65 years, inclusive.
- •3. Body weight (in light clothing and no shoes) =35 kg.
- •4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale [Section 13.4] on smear microscopy) at the trial laboratory.
- •5. DS-TB participants defined as the following:
- •a. Sensitive to rifampicin and isoniazid by rapid sputum-based test AND
- •b. Either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB.
- •6. A chest x-ray during the screening period or within 14 days of screening which in the opinion of the investigator is compatible with pulmonary TB.
- •7. Be of non-childbearing potential OR using effective methods of birth control
排除标准
- •1. History or presence of pulmonary, hepatic, musculoskeletal abnormalities, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychiatric disease
- •2. Cardiovascular abnormalities
- •3. Karnofsky performance status score of <60%.
- •4. Abuse of alcohol or illegal drugs
- •5. Historical and/or current use of local traditional medications/herbs (such as St. John’s wort)
- •6. Being, or about to be, treated for malaria.
- •7. Is critically ill and, in the judgment of the investigator, has a diagnosis likely to result in death during the trial or the follow-up period.
- •8. Any evidence of extrapulmonary TB. Pleural effusion occupying <50% of hemithorax or concomitant intra- or extra-thoracic lymphadenopathy are not exclusions.
- •9. For participants living with HIV (as specified by protocol).
- •10. Having participated in other clinical trials with investigational agents within 8 weeks prior to Day 1 or currently randomised in an investigational drug trial.
- •11. Participants with QTcF interval on ECG >450 msec at screening visit.
- •12. Participants with any of the following at the screening visit per medical history: a. A personal or family history of congenital QT prolongation, b. A history of known, untreated, and uncontrolled hypothyroidism, c. A history of or ongoing bradyarrhythmia, d. A history of Torsade de Pointe.
- •13. Unstable Diabetes Mellitus which required hospitalization for hyper- or hypo-glycemia within the past year prior to the start of screening.
- •14. Females who have a positive pregnancy test during the screening visit or are already known to be pregnant, breastfeeding, or planning to conceive a child during the trial or
- •within 6 months of completing treatment with IMP. Males planning to conceive a child during the trial or within 6 months of stopping treatment with IMP.
- •15. Any diseases or conditions in which the use of standard TB drugs or any of their components is contra-indicated, including but not limited to drug allergy.
- •16. Use of any drug within 30 days prior to randomisation known to prolong QTc interval.
研究者
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